BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JRY UNI TIB BASE TRL SZ1 RM/LL

    MDR report key: 10805839 · Received November 6, 2020

    Report

    Report Number
    1020279-2020-06284
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 16, 2020
    Report Date
    May 9, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HSX
    UDI-DI
    03596010588180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED AT THIS TIME. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCH. THIS DEVICE IS A REUSABLE INSTRUMENT THAT CAN BE EXPOSED TO NUMEROUS SURGERIES; DAMAGE FROM REPEATED USE CAN OCCUR. DAMAGE FROM PROLONGED USE, MISUSE OR ROUGH HANDLING ARE LIKELY PROBABLE CAUSES OF THE REPORTED EVENT. WE RECOMMEND THAT ALL REUSABLE INSTRUMENTS BE ROUTINELY INSPECTED FOR WEAR AND DAMAGE AND REPLACED AS NECESSARY. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UNPACKING, IT WAS FOUND THAT THERE WAS NO ENGRAVED MODEL INFORMATION ON THE JOURNEY UNI TIBIAL BASE TRIAL SZ 1 RM/LL. THERE WAS NO CASE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262441 JRY UNI TIB BASE TRL SZ1 RM/LL PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER HSX SMITH & NEPHEW, INC. 71436151 19MM08834 03596010588180

    Patients

    Seq Age Sex Outcome Treatment
    1